Risk Assessment Rewards
By Aine Cryts
Vol. 22 No. 2 P. 22
Determining breast cancer risk pays dividends.
There was a history of cancer in a second-degree relative. Otherwise, the woman in her mid-thirties was just living her life; she was married and raising two young children. She had been experiencing some back pain, so she had it checked out during a routine health assessment with her primary care provider.
This relatively young woman then got the shock of her life: The diagnosis was metastatic breast cancer, which had spread to the bone and lymph nodes. She died and left behind her husband, a 14-month-old toddler, and a daughter in the second grade, says Stacy Smith-Foley, MD, a radiologist and medical director of CARTI Cancer Center’s breast cancer center in Little Rock, Arkansas. The woman was in Smith-Foley’s close circle of friends.
Stories like this “hurt my heart,” Smith-Foley says. There were options available to this young woman, such as risk assessment and testing for gene mutations. “It feels like a failure of the system [when this happens],” she laments.
This young woman’s experience personifies the responsibility health care providers have. “We need to do more for [these women],” Smith-Foley says.
Risk Assessment Guidelines
Technology can help providers get the risk assessment information they need, Smith-Foley says, but “fancy software” isn’t required. “You don’t have to have a full-time staff member to do this,” she says. “It can be as simple as a paper form where you use NCCN [National Comprehensive Cancer Network] guidelines.”
According to the NCCN, the organization’s breast cancer prevention and risk assessment/management strategies are applicable in the following scenarios:
• Among people with average risk or the general population, regular screening is performed. This is covered in the NCCN Guidelines for Breast Cancer Screening and Diagnosis. While the guidelines are not for risk assessment, they help providers detect breast cancer as early as possible.
• For people with increased risk for breast cancer due to nongenetic issues, providers should consult the NCCN Guidelines for Breast Cancer Risk Reduction.
• For people with increased risk for breast cancer due to genetics, providers should consult the NCCN Guidelines for Genetics/Familial High Risk Assessment.
• For people who have had breast cancer in the past, providers should consult the NCCN Guidelines for Breast Cancer to reduce the risk of recurrence.
Patients are referred to Smith-Foley’s practice, which includes a high-risk clinic where women in the high-risk category are seen twice a year. The clinic is staffed by a nurse practitioner who collaborates with Smith-Foley, a medical oncologist, and a breast surgeon.
Patients are asked what Smith-Foley calls the “red-flag questions” about topics such as their family history and age. Her practice relies on a mammography database software program to capture this information from patients and then generate a personalized risk assessment. That information is also pulled into the radiologist’s structured report, which includes the radiologist’s interpretation of the mammography exam.
Initially, patients input responses to questions in a tablet. Then, a technologist will ask the patient for more detailed information, which is combined into the report. At that point, the software generates a personalized risk assessment, which is provided to the primary care provider and the patient.
The information is translated into patient-friendly terms, Smith-Foley says. For example, the patient may be told that they are at elevated risk of having breast cancer and they have dense breast tissue; at that point, they’ll be informed about services the practice can provide, such as ultrasound, MRI screening, or genetic testing.
Genetic testing also offers transformational insight to patients. “When you find a patient who has a genetic mutation, you find out that you’ve altered the course of their life,” Smith-Foley says. “They’re no longer a ‘sitting duck.’ They’re in the ‘driver’s seat.’”
CAD and AI
Mammograms contain a wealth of data about women, even beyond their breast density, says Emily Conant, MD, division chief of breast imaging at Penn Medicine. The data in the mammogram can further refine risk assessment, she adds. She uses computer-aided detection (CAD) software alongside AI in her research.
Combining these software tools can help predict long-term changes in a woman’s breasts and short-term outcomes, Conant says. She uses iCAD's Profound AI for digital breast tomosynthesis product on a trial basis in her research. This research is important because, according to a study abstract, approximately one-fourth of women who develop breast cancer do so within two years of getting a negative screening.
According to Nashua, New Hampshire–based iCAD, its software helps radiologists address the challenges of reading tomosynthesis cases by improving cancer detection rates, reducing false-positives and unnecessary patient recalls, and decreasing reading times. Mike Klein, chairman and CEO at iCAD, observes that there are two key variables that help assess a woman’s chances of developing breast cancer: her age and the current images of her breasts. He also cites an article in Expert Review in Molecular Diagnostics by Axel Gräwingholt, MD, a radiologist at Radiologie am Theater, a Paderborn, Germany–based radiology practice. In the article, Gräwingholt found that the use and combination of AI tools for detection and risk assessment may help in the detection of breast cancers in future screenings in a personalized way.
This approach with CAD and AI takes into account that each woman experiences a different risk of developing breast cancer and that radiologists can experience challenges detecting cancers, according to Gräwingholt. He also observed that this approach may lead to a reduction in the cost of screening programs, since stratification can be used to screen each woman. Additional benefits, according to Gräwingholt, are a potential reduction in the harm of diagnosis and overtreatment.
Wellington, New Zealand–based Volpara Health Technologies also has a platform that provides radiologists with insights about women who are at high risk of developing breast cancer. Called VolparaRisk, the solution supports radiologists in determining appropriate supplemental screening and testing.
According to the company, VolparaRisk helps expedite risk assessment by capturing patient data electronically in a comprehensive questionnaire. The software performs risk calculations using various models, including Tyrer-Cuzick version 8 and, ultimately, gives the interpreting radiologist risk information at the workstation. Ralph Highnam, PhD, CEO of Volpara Health Technologies, says that more than 1 in 4 breast cancer screenings in the United States use the company’s software, and approximately 15% of their customers are using the risk assessment platform.
Educating Patients and Providers
While the average woman has a 1 in 8 risk of developing breast cancer, defining the word “average” is a significant challenge because that insight drives when a woman starts getting mammograms and how often, says Nina Vincoff, MD, chief of breast imaging at Northwell Health in New Hyde Park, New York.
Most women don’t know whether they’re at average or high risk, and that’s the problem, she explains. A woman’s primary care physician or obstetrician-gynecologist has a lot to cover during a typical annual visit, which doesn’t leave much time to determine her risk of having breast cancer. An equal challenge is that many of these physicians can’t advise patients on steps to take if they are at increased risk of having breast cancer.
To address this gap, Vincoff says breast imaging specialists need to make a concerted effort to educate radiologists and their primary care, internal medicine, and obstetrics-gynecology colleagues about the value and promise of risk assessment for their patients.
Another important factor is whether the patient’s health insurance will cover advanced imaging and genetic testing, Vincoff says. She points out that this varies by state. In New York, where she practices, cost sharing by patients has been removed for mammograms in the following scenarios:
• a single baseline mammogram for women 35 to 39 years of age;
• yearly mammograms for women 40 years of age or older; and
• mammograms for women at any age who are at an increased risk of breast cancer because they have a prior history of breast cancer or a first-degree relative, such as a parent, sibling, or child, with breast cancer.
Cost sharing is also removed for women who need diagnostic mammograms, breast ultrasounds, and breast MRI to detect breast cancer. That said, health insurers in New York aren’t required to cover advanced imaging. According to the New York State Department of Health, “If the insurer determines a breast ultrasound or breast MRI is medically necessary, the law requires the service to be covered at no cost to the patient when it is provided by a participating provider. If an insurer determines a breast ultrasound or breast MRI is not medically necessary, the insured individual has the right to an internal and external appeal of that decision.”
Every woman who has a mammogram at Vincoff’s practice is asked questions based on the Tyrer-Cuzick model. This tool, which calculates an individual's likelihood of carrying the BRCA1 or BRCA2 mutations, also estimates a woman’s chance of having breast cancer in the next 10 years and her lifetime. If a woman has a 10% or greater chance of a mutation in BRCA1, BRCA2, or both, she should have access to genetic counseling, according to Medscape.
Current age, age of first menstruation, body mass index, obstetric history, age at menopause (if applicable), history of benign breast conditions and ovarian cancer, hormone replacement therapy use, and family history are risk factors used in the Tyrer-Cuzick model, per Medscape, which reported that this model is “the most consistently accurate” when compared to the Gail, Claus, and Ford models. But any risk assessment tool is better than nothing, Vincoff says. She adds that there are free risk assessment calculators available online.
Because the Tyrer-Cuzick model can be a bit unwieldy, a technologist in Vincoff’s practice asks the questions and plugs the patient’s responses into the risk calculator after the patient submits the initial responses. While this requires a significant initial time investment by the patient and the technologist, Vincoff feels it’s worth it because it delivers a better, more accurate risk assessment.
Public Health Challenges
Primary care providers, internal medicine physicians, obstetrician-gynecologists, and radiologists who don’t specialize in breast imaging “all have to share responsibility for this effort,” Vincoff says. “We have a real opportunity to do more than just find cancer. We have an opportunity to educate women ... and empower them to take the next step.”
Educating women includes having a conversation about dense breast tissue. At Vincoff’s practice, each woman with dense breast tissue receives a call from a nurse to discuss what this means for the woman’s health and learn about any supplementary imaging that may be helpful. Vincoff regularly speaks with patients, but that’s not true for all radiologists or breast imaging specialists. When an in-person or phone consult isn’t an option, she advises the interpreting radiologist to take time to write their assessment in the patient’s report in patient-friendly language.
Vincoff is a strong advocate for educating women about their risk of developing breast cancer before they have their first mammogram. That’s particularly the case for Black and Ashkenazi women.
While Black women and white women get breast cancer at approximately the same rates, Black women are more likely to die as a result, according to the Centers for Disease Control and Prevention (CDC). Per the CDC, Black women are also more likely to get triple-negative breast cancer, which is often aggressive and returns after treatment. The agency also notes that 1 in 40 Ashkenazi Jewish women has a BRCA gene mutation, which brings a higher risk of developing breast cancer at a young age.
“It always tugs at me,” Vincoff says. “If you’re high risk, you really need to know before your first mammogram ... I can’t provide a risk assessment before she turns 30 if I don’t see her [in my practice].”
— Aine Cryts is a health care writer based in the Boston area.